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NCT07732062
vEAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Feasibility Study
Conditions: Chronic Musculoskeletal Pain, Cannabis Use
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 42
Sponsor: Reuth Rehabilitation Hospital
Location: Reuth Rehabilitation Hospital Tel Aviv
Summary
The goal of this clinical trial is to evaluate whether a culturally adapted, virtual, group-based emotional therapy called Emotional Awareness and Expression Therapy is feasible and whether it can help reduce chronic pain and improve emotional well-being among Israeli adults who suffer from chronic musculoskeletal pain and are treated with medical cannabis.
Participants will attend a weekly 1.5-hour virtual group therapy session for 8 weeks, except for the first session, which will be held in-person at the hospital's clinic. The participants will take part in group discussions and emotional processing exercises, complete questionnaires about pain levels, mood, sleep, and quality of life, and continue their usual medical treatment as prescribed by their doctors.
Eligibility Criteria
Inclusion Criteria:
1. Diagnosed with any chronic musculoskeletal pain (≥ three months in duration) including back, neck, limb or pelvic pain, tension headache and fibromyalgia;
2. Treated with medical Cannabis;
3. Physical and mental ability to participate in group discussions;
4. Fluent in reading and speaking Hebrew.
Exclusion Criteria:
1. Chronic pain conditions not classified as chronic primary pain. These include neuropathies such as carpal or tarsal tunnel syndrome, radiculopathy, and neuralgia;
2. Primary headache disorders such as cluster headaches;
3. Cancer-related pain;
4. Burn- or infection-related chronic pain;
5. Autoimmune diseases typically associated with pain, including rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, systemic lupus erythematosus, and sickle cell disease;
6. Inflammatory systemic diseases causing pain, including osteoarthritis or gout.
7. Severe mental illness or psychiatric disorder such as schizophrenia, bipolar I disorder, multiple personality disorder, or dissociative identity disorder not controlled with medications, active suicide or violence risk in the past year, active severe alcohol or substance use disorder, self-reported use of intravenous drugs.
8. Participant with a significant negative life event within the past six months, such as the death of a close person, significant loss of income, or another traumatic or highly stressful event, which may substantially affect the participant's emotional state, safety, or ability to participate in the intervention;
9. Current participation in another psychological or behavioral therapy, program, or clinical study.
Source: ClinicalTrials.gov (NCT07732062). StuddyBuddy aggregates publicly available trial information.